Use Of SB-705498 In The Acute Treatment Of Migraine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00269022

Purpose

Despite the success of the triptan class of drugs, approximately 60% of patients who take medication at the moderate to severe pain stage of acute migraine, still have pain of mild or greater degree at 2 hrs post dose. SB-705498 is a novel, first in class TRPV1 receptor antagonist under development for the treatment of migraine pain. Preclinical experiments have demonstrated that the TRPV1 receptor is expressed both centrally and peripherally in the trigeminal system and inhibition of TRPV1 with SB-705498 can both prevent and reverse established central sensitisation.

Condition	Intervention	Phase
Migraine, Acute	Drug: SB-705498	Phase II

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Crossover Assignment, Efficacy Study
Official Title:	A Single Blind, Placebo Controlled, Multi-Centre Study to Investigate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of the TRPV1 Antagonist SB-705498 Against the Pain of Acute Migraine.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percentage of subjects who are pain free at 2 hrs post-dose (e.g., have moderate to severe pain at baseline and no pain at 2 hrs post-dose).

Secondary Outcome Measures:

Pain free at 30mins, 1,3,4,5&6hrs Headache relief and absence/presence of associated symptoms at 30 mins, 1,2,3,4,5&6hrs Additional migraine medication Safety tests ( e.g., continuous ECG, laboratory tests) Heat pain thresholds.

Estimated Enrollment:	70
Study Start Date:	January 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Healthy subjects suffering from moderate to severe migraine headache with or without aura.
Women of child bearing potential must use an effective method of contraception.
Have had at least a 1 year history of migraine and the age of onset was prior to 50 years.
Suffering 1 to 6 migraine attacks per month for at least the last 3 months and should have at least 48 hours free of headache between migraine attacks.

Exclusion criteria:

Headache for 15 days/month or greater in any of the three months (90 days) preceding entry into the study.
Use of migraine medications (e.g., ergotamine, triptan, opioid, or combination medication) on >/= 10 days per month on a regular basis for >/= 3 months.
Use of analgesics >/=15 days per month for >/=3 months, uses an opiate (except codeine) as first line treatment for migraine.
Migraine symptoms do not respond to any of the triptan drugs (e.g., Imitrex, Relpax, Maxalt).
Have uncontrolled hypertension or a history/ presence of multiple cardiovascular risk factors such as, but not limited to family history, myocardial infarction, coronary artery disease, vasospastic angina, heart failure, cardiac arrhythmias or history or presence of cerebrovascular disease, including transient ischemic attack, stroke or peripheral arterial disease.
History of alcohol, substance or drug abuse within the last year.
Participation in a trial with a new chemical entity within 3 months before the start of the study.
Participation in any other research trial within 30 days prior to the first dose of current study medication is not permitted.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269022

Locations

Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Canada, Ontario
GSK Investigational Site
Toronto, Ontario, Canada, M1L 4S4
Netherlands
GSK Investigational Site
LEIDEN, Netherlands, 2333 ZA
United Kingdom, Cambridgeshire
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 2GG

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SB-705498/008
Study First Received:	December 21, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00269022
Health Authority:	Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:

SB-705498 acute migraine single dose TRPV1 combination inpatient outpatient study

Study placed in the following topic categories:

Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary

Pain
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009